Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study.

Caplin ME, Pavel M, Phan AT, Ćwikła JB, Sedláčková E, Thanh XT, Wolin EM, Ruszniewski P

Endocrine14 Oct 2020Cited by 64 (Europe PMC)

PMID33052555PMCIDPMC7881960DOI10.1007/s12020-020-02475-2PepBankPUB-33052555

Summary

PurposeIn the phase III CLARINET study (NCT00353496), lanreotide autogel/depot (lanreotide) significantly improved progression-free survival (PFS) vs placebo in patients with non-functioning intestinal or pancreatic neuroendocrine tumours (NETs). The aim of CLARINET open-label extension (OLE) (NCT00842348) was to evaluate long-term safety and efficacy of lanreotide in these patients.MethodsPatients from the CLARINET study were eligible for the OLE if they had stable disease (irrespective of treatment group) or progressive disease (PD) (placebo-treated patients only). All patients in the OLE received lanreotide 120 mg every 28 days. Computed tomography or magnetic resonance imaging scans were conducted every 6 months and assessed locally for PD (the final scan was also assessed centrally).ResultsOverall, 89 patients took part in the OLE (lanreotide, n = 42; placebo, n = 47). Median (range) exposure to lanreotide in patients who received lanreotide in the core study and OLE (LAN-LAN group) was 59.0 (26.0-102.3) months. In this group, the overall incidences of adverse events (AEs) and treatment-related AEs were lower in the OLE than in the core study. Median [95% CI] PFS in the LAN-LAN group was 38.5 [30.9; 59.4] months. In placebo-treated patients with PD at the end of the core study, time to death or subsequent PD during the OLE was 19 [10.1; 26.7] months.ConclusionsThis study provides new evidence on the long-term safety profile and sustained anti-tumour effects of lanreotide autogel/depot in indolent and progressive metastatic intestinal or pancreatic NETs.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanNon-randomized trialSafety outcome
In NET patients continuing lanreotide, overall adverse event incidence was lower in the extension than in the core study.
In plain wordsIn NET patients continuing lanreotide, adverse events were less frequent in the extension than in the core study.
Peptide
Lanreotide
Outcome
DecreaseOverall adverse event incidence
Study
n = 42
Comparator
core study
Outcome group
Adverse events · Whole body
Studied dose
120 mg every 28 daysAs given in this study (human).
Source sentences
Summary
In this group, the overall incidences of adverse events (AEs) and treatment-related AEs were lower in the OLE than in the core study.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients from the CLARINET study were eligible for the OLE if they had stable disease (irrespective of treatment group) or progressive disease (PD) (placebo-treated patients only). All patients in the OLE received lanreotide 120 mg every 28 days.
Show in the study text Report a problemFND-3305255501
02HumanNon-randomized trialSafety outcome
In NET patients continuing lanreotide, treatment-related adverse event incidence was lower in the extension than in the core study.
In plain wordsIn NET patients continuing lanreotide, treatment-related adverse events were less frequent in the extension than in the core study.
Peptide
Lanreotide
Outcome
DecreaseTreatment-related adverse event incidence
Study
n = 42
Comparator
core study
Outcome group
Adverse events · Whole body
Studied dose
120 mg every 28 daysAs given in this study (human).
Source sentences
Summary
In this group, the overall incidences of adverse events (AEs) and treatment-related AEs were lower in the OLE than in the core study.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients from the CLARINET study were eligible for the OLE if they had stable disease (irrespective of treatment group) or progressive disease (PD) (placebo-treated patients only). All patients in the OLE received lanreotide 120 mg every 28 days.
Show in the study text Report a problemFND-3305255502
03HumanNon-randomized trialEfficacy outcome
In NET patients receiving lanreotide in both studies, median progression-free survival was 38.5 months (95% CI 30.9-59.4).
In plain wordsIn NET patients receiving continued lanreotide, median progression-free survival was 38.5 months.
Peptide
Lanreotide
Outcome
Not applicableProgression-free survival with continued lanreotide
Study
n = 42
Outcome group
Tumor growth · Cancer
Studied dose
120 mg every 28 days · median exposure 59.0 months (range 26.0-102.3) in the LAN-LAN groupAs given in this study (human).
Measurements
Median progression-free survival
38.5 months
LAN-LAN group
95% CI of median progression-free survival
30.9 to 59.4 months
LAN-LAN group
Source sentences
Summary
Median [95% CI] PFS in the LAN-LAN group was 38.5 [30.9; 59.4] months.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients from the CLARINET study were eligible for the OLE if they had stable disease (irrespective of treatment group) or progressive disease (PD) (placebo-treated patients only). All patients in the OLE received lanreotide 120 mg every 28 days.
Show in the study text Report a problemFND-3305255503
04HumanNon-randomized trialEfficacy outcome
In NET patients progressing on placebo before lanreotide, time to death or subsequent progression was 19 months (95% CI 10.1-26.7).
In plain wordsAfter placebo progression, NET patients receiving lanreotide had 19 months to death or subsequent progression.
Peptide
Lanreotide
Outcome
Not applicableTime to death or subsequent progression after placebo progression
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
120 mg every 28 daysAs given in this study (human).
Measurements
Median time to death or subsequent progression
19 months
placebo-treated patients with PD at end of core study, during OLE
95% CI of median time to death or subsequent progression
10.1 to 26.7 months
placebo-treated patients with PD at end of core study, during OLE
Source sentences
Summary
In placebo-treated patients with PD at the end of the core study, time to death or subsequent PD during the OLE was 19 [10.1; 26.7] months.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients from the CLARINET study were eligible for the OLE if they had stable disease (irrespective of treatment group) or progressive disease (PD) (placebo-treated patients only). All patients in the OLE received lanreotide 120 mg every 28 days.
Show in the study text Report a problemFND-3305255504

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00842348

Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour

Ipsenn = 89Feb 2009 to Dec 2015

Non Functioning Entero-pancreatic Endocrine Tumour

Trial page ClinicalTrials.govUpdated 12 Oct 2022

CompletedPhase 3Results postedNCT00353496

Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

Ipsenn = 264Jun 2006 to Apr 2013

Endocrine Tumors

Trial page ClinicalTrials.govUpdated 5 Mar 2025

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

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